Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease

Summary

This is a controlled investigation, with randomization of the patients, which aims at demonstrating the efficacy of device RGn600 in treating patients with mild-to-moderate Alzheimer's disease (AD). RGn600 is a non-invasive medical device which is applied on the head (helmet) and on the abdomen (abdominal belt). It combines 2 technologies: * PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs) * Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field. Considering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.

Eligibility

Inclusion Criteria:

* Male or female aged 55 to 85 years old (both included)
* Diagnosed with AD according to McKhann et al. international criteria dated 2011
* With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26
* With blood analyses results (for: thyroid-stimulating hormone, vitamin B12, folate, complete blood count including platelets, electrolytes including calcium, creatinine, clearance, alanine aminotransferase, aspartate aminotransferase, bilirubin, coagulation, C-reactive protein) dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator
* With brain Computed Tomography (CT) or/and Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator
* In case of treatment with AD symptomatic treatments (memantine and acetylcholinesterase inhibitors) and psychotropic treatments (anxiolytics, antidepressants and neuroleptics): with a stable dose of such treatments 4 weeks before inclusion
* Who has a caregiver who is sufficiently and regularly present and can help the patient throughout the investigation, as deemed by the investigator
* Affiliated to French social security
* Who provided, with his/her caregiver, a dated and signed informed consent form.

Exclusion Criteria:

* Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")
* Patient deprived of liberty or hospitalized without consent
* Non-menopausal woman
* Patient taking a disease-modifying treatment such as the Leqembi® or any other disease-modifying treatment that may be authorized in France before the end of the study
* Patient living in a medical facility
* Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion
* Patient with skin lesions on the treatment application area (abdomen or head)
* Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.)
* Patient diagnosed with a stroke within 3 months prior inclusion
* Patients with ferromagnetic material (i.e., iron, nickel, cobalt or any metal alloy) on or near the head or abdomen, or implanted with a pacemaker
* Patient with a risk of epileptic seizure
* Patient with a genetic form of AD
* Patient with major physical or neurosensorial disorders that may interfere with neurological assessments
* Patient with chronic psychosis or psychotic episodes
* Patient addicted to alcohol or drugs
* Patient with known and non-supplemented vitamin B12 and folic acid deficiencies
* Patient with known untreated hypothyroidism
* Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion
* Patient not able to meet treatment sessions as deemed by the investigator
* Patient not able to complete requested investigation assessments as deemed by the investigator.

Conditions2

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